CIrculating Tumor DNA for Monitoring Response to First Line Chemotherapy in Unresectable PANcreatic Cancer

KRAS (Kirsten Rat Sarcoma) Mutant CIrculating Tumor DNA for Monitoring Response to First Line Chemotherapy in Locally Advanced and Metastatic PANcreatic Cancer

With an incidence of more than 11,600 new cases per year in France and an annual number of deaths close to the incidence rate, adenocarcinoma of the pancreas is a public health problem.

The aim of this study is to assess the predictive value of response to the 1st line of chemotherapy of mutated KRAS ctDNA (circulating tumor DNA) in unresectable metastatic or locally advanced pancreatic adenocarcinomas.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Circulating Tumor DNA; KRAS Mutation-Related Tumors
• Intervention / Treatment: Diagnostic test: Blood samples

Detailed Description

With an incidence of more than 11,600 new cases per year in France and an annual number of deaths close to the incidence rate, adenocarcinoma of the pancreas is a public health problem especially since there is a significant increase in its incidence. incidence (+ 417% between 1980 and 2012).

Most often diagnosed late, pancreatic adenocarcinoma is managed at a metastatic stage in 60 to 70% of cases with a very poor prognosis (8.7 to 11.1 months median survival with current chemotherapies). The first line of chemotherapy therefore represents a major issue in the management of these unresectable patients. There are few predictive markers of response to chemotherapy in pancreatic adenocarcinoma. It is conventionally evaluated by scanner every 2 to 3 months. The response to chemotherapy is associated with a good prognosis while non-response has a poor prognosis and requires a 2nd line of treatment if the patient is able to receive it.

A KRAS mutation is present in approximately 70-90% of pancreatic adenocarcinomas. Its research on tissue sampling (fine needle aspiration or anatomo-pathological specimen) is not carried out routinely because no prognostic or predictive value of KRAS mutations has been demonstrated. New high-throughput DNA sequencing techniques have been developed and now allow a blood sample to detect and quantify circulating tumor DNA (ctDNA), including KRAS mutations.

Very few studies have investigated the change in cDNA levels during 1st line chemotherapy in unresectable pancreatic adenocarcinoma.

The aim of this study is to assess the predictive value of response to the 1st line of chemotherapy of mutated KRAS cDNA in unresectable metastatic or locally advanced pancreatic adenocarcinomas.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Proven pancreatic adenocarcinoma (histology or cytology)
• Metastatic or locally advanced unresectable
• With thoraco-abdomino-pelvic scanner less than a month old
• Chemotherapy treatment regardless of the protocol
• Patients benefiting from a Social Security scheme or benefiting through the intermediary of a third party
• Informed consent signed by the patient after clear and fair information about the study

Exclusion Criteria:

• Linguistic or psychological refusal or inability to understand and / or sign the informed consent
• History of cancer in the 5 years preceding inclusion
• Patient who has already received chemotherapy or radiotherapy for pancreatic cancer.
• Immediately resectable tumor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Only arm; Blood samples to analyze ctDNA	Diagnostic test: Blood samples; Blood samples to determine ctDNA levels during chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of the ctDNA level to the response to chemotherapy	Response to chemotherapy was evaluated with RECIST criteria 1.1 on the first CT scan	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Correlation between variation of ctDNA and overall survival	6 months after last patients inclusion
Progression free survival	Correlation between variation of ctDNA and progression free survival	6 months after last patients inclusion

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2016
• Primary Completion (Actual): June 28, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: September 5, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2020
• Last Update Submitted That Met QC Criteria: September 17, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms; Pancreatic Neoplasms
• Other Study ID Numbers: KRASCIPANC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No